3 Pharma Industry cGMP Compliance Trends

It must be that time again when conference planners rack their brains on how to bolster dwindling attendance, because several have contacted me through this blog to ask my opinion on major trends in the pharmaceutical industry.
So with this edition I offer my opinion not only to those conference planners, but also to my readers. After all, why should you—my loyal readers—have to attend a pricey conference to hear what I told them? But first, a note about—well, these pricey pharmaceutical conferences.

There are certainly worthwhile conferences in the pharma industry, but you really have to consider whether they are worth it. I have always thought that the best conferences were those with a strong FDA presence on the speaker roster. However, FDA speaker materials eventually become accessible to the general public. So, shortly thereafter, you can Google the name of the FDA speaker you saw in the pre-conference e-brochure and bingo. If it’s content you’re after, why not use your favorite search engine?

The worst conferences of them all are those that recycle the same industry consultants. But I’ll save that subject for another time.

So—now to the subject at hand: current pharmaceutical industry CGMP compliance trends. Here are the top three, in my opinion:

1. There is an emboldened FDA intent on measuring up under a keenly interested Congress. There are sixteen (16) major pharma consent decrees dating from 1989 to 2010. What do they all have in common? No, it’s actually not bodies in the street. It’s cGMP violations. Of these, only six (6) consent decrees have been vacated.